Trial Outcomes & Findings for On-Eye Evaluation of Contact Lens Rotation Marks (NCT NCT02055404)

Results Overview

Each lens (containing 8 rotation marks and one reference mark, in total 9 marks) was assessed for visibility by 10 investigators using the following scale: "N/A;" "Not visible;" "Slightly visible, not acceptable;" "Slightly visible, acceptable;" "Clearly visible;" "More visible than necessary." Visibility assessments were made after all marks had been evaluated. S9 Mark (test lens) functioned as a starting marker only and was not rated. The control lens was not used as a comparison, but rather as a reference for what a mark looks like on a commercial product. "Visibility of Rotation Mark" is reported as the percentage of assessments rating the rotation mark as "Clearly visible" or "Slightly visible, acceptable."

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

Day 1

Results posted on

2014-04-02

Participant Flow

Participants were recruited from 1 US study center.

This reporting group includes all enrolled participants.

Participant milestones

Participant milestones
Measure	Overall Study Delefilcon A spherical contact lens with molded marks and etafilcon A toric contact lens worn contralaterally (1 in each eye) for approximately 2 hours
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

On-Eye Evaluation of Contact Lens Rotation Marks

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=3 Participants Delefilcon A spherical contact lens with molded marks and etafilcon A toric contact lens worn contralaterally (1 in each eye) for approximately 2 hours
Age, Continuous	46.0 years STANDARD_DEVIATION 21.3 • n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: Day 1

Population: The analysis population includes all enrolled participants. Assessments from all 10 investigators were analyzed, hence sample size for each rotational mark is 30.

Each lens (containing 8 rotation marks and one reference mark, in total 9 marks) was assessed for visibility by 10 investigators using the following scale: "N/A;" "Not visible;" "Slightly visible, not acceptable;" "Slightly visible, acceptable;" "Clearly visible;" "More visible than necessary." Visibility assessments were made after all marks had been evaluated. S9 Mark (test lens) functioned as a starting marker only and was not rated. The control lens was not used as a comparison, but rather as a reference for what a mark looks like on a commercial product. "Visibility of Rotation Mark" is reported as the percentage of assessments rating the rotation mark as "Clearly visible" or "Slightly visible, acceptable."

Outcome measures

Outcome measures
Measure	S1 Mark n=3 Participants Delefilcon A spherical contact lens with 1 of 9 molded marks	S2 Mark n=3 Participants Delefilcon A spherical contact lens with 1 of 9 molded marks	S3 Mark n=3 Participants Delefilcon A spherical contact lens with 1 of 9 molded marks	S4 Mark n=3 Participants Delefilcon A spherical contact lens with 1 of 9 molded marks	S5 Mark n=3 Participants Delefilcon A spherical contact lens with 1 of 9 molded marks	S6 Mark n=3 Participants Delefilcon A spherical contact lens with 1 of 9 molded marks	S7 Mark n=3 Participants Delefilcon A spherical contact lens with 1 of 9 molded marks	S8 Mark n=3 Participants Delefilcon A spherical contact lens with 1 of 9 molded marks	Control n=3 Participants Etafilcon A toric contact lens
Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable)	42.9 Percentage of assessments	71.4 Percentage of assessments	78.6 Percentage of assessments	46.4 Percentage of assessments	71.4 Percentage of assessments	82.1 Percentage of assessments	78.6 Percentage of assessments	75.0 Percentage of assessments	93.3 Percentage of assessments

Adverse Events

Delefilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Etafilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joachim Nick, Dipl. Ing.

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place